Adaptation of the PCIP for Children Aged 6 to 11

NCT ID: NCT05606172

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-08-01

Brief Summary

This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smartphone delivery), to 10 youth age 6-11 and their caregivers.

Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness.

Following RE-AIM guidelines, the investigators will assess:

1. Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions)

2. Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings.

To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers.

This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.

Conditions

Post-Traumatic Stress Disorder in Children; Post-traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCIP for youth aged 6 to 11

This arm will receive the adapted PCIP intervention lasting from 1-4 weeks, and will complete baseline, post treatment, 1-month, and 3-month follow up assessments.

Group Type: EXPERIMENTAL

Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11

Intervention Type: BEHAVIORAL

This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.

Waitlist Treatment as Usual

Receive standard care treatment and will complete baseline, post treatment, 1-month, and 3-month follow up assessments, and are offered PCIP treatment after conclusion of the study.

Group Type: ACTIVE_COMPARATOR

Waitlist Treatment as Usual

Intervention Type: BEHAVIORAL

Will receive treatment as usual at local clinic and are provided information on free or low cost mental health care referrals in the Los Angeles Area.

Interventions

Primary Care Intervention for PTSD (PCIP) Youth aged 6 -11

This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.

Intervention Type: BEHAVIORAL

Waitlist Treatment as Usual

Will receive treatment as usual at local clinic and are provided information on free or low cost mental health care referrals in the Los Angeles Area.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Patient referred to the SHARK Program

2. Patients must be at least 6 years old

3. The patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study;

4. Patient is able to complete study activities in English.

Exclusion Criteria

1. Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;

2. Inability to provide informed consent or assent, and/or complete procedures in English.

3. Patient is over the age of 11

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lauren Ng, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren C Ng, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA Psychology

Locations

University of California Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

22-001441

Identifier Type: -

Identifier Source: org_study_id